QA Specialist

Do you want to join one of the fastest-growing molecular diagnostics startups and develop products that can affect the lives of millions?

BillionToOne (Y Combinator S17), ranked at the top 5% of Y Combinator companies with $200M+ in funding from prominent VC firms, has developed a DNA molecular counter that increases the cell-free DNA diagnostics resolution by over 1,000 fold. BillionToOne's first product, UNITY™ is the first and only prenatal screen that directly assesses the baby's risk for common and severe inherited disorders such as cystic fibrosis, spinal muscular atrophy (SMA), and hemoglobinopathies from a single tube of blood from the pregnant mother.

We are looking for a Quality Assurance Specialist to own all quality activities related to the clinical laboratory, including activities related to pre-analytical, analytical and post analytical phases. The Quality Assurance Specialist is an onsite position and will report to the Associate Director of Quality Assurance.

Responsibilities:

• Owns all quality activities related to the clinical laboratory, including activities related to pre-analytical, analytical and post analytical phases
• Support clinical laboratory related issues and work closely to determining root cause and potential preventative/corrective actions
• Review any laboratory validation life cycle documentation including, protocols, forms, and reports.
• Maintenance of equipment lifecycle, patient, processing, and facility records, personnel training and competency, proficiency testing, and document control system.
• Assist on trending analysis (Quality Metrics) on a routine basis by identifying, generating and publishing metrics and reports related to the Quality System performance and reporting anomalies to management
• Plays key role in supporting preparation and onsite support during site surveys and audits by regulatory agencies.
• Represent Quality at cross functional meetings.
• Support other routine Quality processes such as document control, employee training, investigations, equipment qualifications, internal audits, as required and directed by Manager.
• Execute special projects as assigned by Manager.
• Report and document all concern of test quality and/or safety to the Manager or Safety Officer, as applicable.
• Conduct routine laboratory walk-throughs/ quality inspections/ system audits and create findings reports.

Requirements:

• 5+ years of experience in Clinical lab or molecular diagnostics setting. 
• B.S. degree in a scientific discipline, preferably Medical Technology, Clinical Laboratory Science, or other related Life Sciences required.
• Experience with process improvement and process implementation in a high growth environment.
• Experience in a CLIA/CAP laboratory (high complexity testing), quality experience required
• Ability to work effectively in a team environment and build strong working relationships
• Ability to successfully balance and prioritize multiple ongoing projects/tasks in a fast-paced, deadline driven environment
• Ability to identify, analyze and solve problems with minimal direction and escalate concerns to management
• Proven attention to detail and accuracy
• High degree of initiative and self-motivation

Nice-To-Haves:

• Possess a valid Clinical Laboratory Scientist Generalist (CLS) or Clinical Genetic Molecular Biologist Scientist (CGMBS) license issued by the California Department of Public Health (CDPH)
• MS in Regulatory Affairs/ Quality Management, Six Sigma Certification, American Society for Quality (ASQ) Certifications.

Benefits and Perks

• Competitive pay
• Generous equity package
• Suite of benefit plans; employee premiums paid 90% of Gold PPO plan
• Extremely generous Medical, Pregnancy, Parental and Family Leaves
• Retirement savings program with 4% Company matching
• Free daily on-site lunches provided from top eateries
• Latest and greatest hardware (laptop, lab equipment, facilities)
• A variety of perks on campus (state of the art gym, restaurant)
• Free on-site EV charging (compatible with all EVs, including Tesla)
• Working with a team of ‘rockstars’ who bring out the best in everyone
• The ability to indirectly or directly change the lives of hundreds of thousand patients
• Open, transparent culture that includes weekly Town Hall meetings

At BillionToOne, we are proud to offer a combination of a (1) base pay range (actual amount offered is based experience and salary/equity options split that the candidate chooses) (2) generous equity options offering, on top of (3) industry leading company benefits (free healthcare options, 401k match, very generous fully paid paternal leave etc.).

For this position, the base pay range is: $135,000 to $145,000 per year

BillionToOne is an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.